On November 8, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported dosing of the first patient under its collaboration agreement with BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) in a Phase 1b clinical trial to assess the safety and tolerability, pharmacokinetics and preliminary anti-tumor activity of Mirati’s sitravatinib in combination with BeiGene’s investigational anti-PD1 antibody, tislelizumab, in patients with advanced solid tumors (Press release, Mirati, NOV 8, 2018, View Source [SID1234531086]). The clinical trial is currently enrolling patients in China and Australia.
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"We’re excited to move into the next phase of our collaboration with BeiGene. BeiGene’s ability to rapidly enroll patients into this clinical trial has the potential to significantly expand and accelerate our development efforts for sitravatinib and provide access to additional patient populations," said Charles Baum, M.D., Ph.D., President and Chief Executive Officer of Mirati. "This clinical trial also has the potential to provide proof of concept clinical data in multiple solid tumor types."
This initial open-label, multicenter, non-randomized Phase 1b clinical trial is designed to assess the safety and tolerability in patients with histologically or cytologically confirmed locally advanced or metastatic non-squamous, non-small cell lung cancer (NSCLC), renal cell carcinoma, and ovarian cancer. Patients will receive 120 mg of oral sitravatinib, daily, and 220 mg of intravenous tislelizumab, every three weeks.
"This collaboration has progressed quickly, and we are pleased that we can investigate the potential complementary activity of sitravatinib and tislelizumab in patients with advanced solid tumors in China and Australia," said Amy Peterson, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene.
Under the terms of the collaboration agreement, upon initiation of the clinical trial by BeiGene, Mirati will receive a $3 million milestone payment.
About Sitravatinib
Sitravatinib is a spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients who have experienced documented disease progression following treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation.
Sitravatinib is also being evaluated as a single agent in a Phase 1b expansion clinical trial enrolling patients whose tumors harbor specific mutations in the CBL protein. When CBL is inactivated by mutation, multiple RTKs, including TAM, VEGFR2 and KIT, are dysregulated and may act as oncogenic tumor drivers in NSCLC and melanoma. Sitravatinib potently inhibits these RTKs and is being investigated as a treatment option for cancer patients with CBL mutations.